Scott Clemson loves his wide, open spaces, with plenty of empty between where he is and where he’s going. Lacing up his hiking shoes and hitting the trails makes him feel alive. “I’ll just go out exploring, sometimes with an agenda, but a lot of times it’s just going out and exulting in seeing wildlife and the scenery. It’s one of the things that makes me glad to be alive, in a human body, on the planet Earth.”
One major reason that Clemson can explore the solitude of the desert, roam alone among the foothills and sometimes walk and run miles without seeing another person is because he is part of an expansive, unique and growing community.
He doesn’t get together with the others for potlucks, game nights or even long walks. If he runs into fellow community members at the store, he doesn’t know it, nor will they recognize him. This community does not live in one city, or even one state or country.
Living in a Medical Community
Clemson is one of the now over 150,000 people around the world who have been treated with MitraClip Transcatheter Mitral Valve Repair (TMVr) therapy. If everyone who received one of the four generations of the device since its commercial introduction in 2008 was alive and in the same geographic area, it would be roughly the population of cities the size of Pasadena, Calif., Dayton, Ohio or Syracuse, N.Y.
MitraClip treats people with primary or secondary mitral regurgitation (MR), also known as a leaky heart valve. MR is a condition in which there’s a problem with the mitral valve: the valve’s leaflets, or flaps, that should open and close to allow proper blood flow aren’t able to close effectively. Rather than allowing blood to flow out to the body as it should, the faulty valve causes blood to move backward within the heart, disrupting proper blood flow. Furthermore, because of this regurgitation, the heart’s left chamber may become enlarged, making it difficult for the heart to pump blood. The condition is progressive and can worsen over time without treatment.
Clemson knows all about that worsening condition part.
Surviving in a Community
“I learned I had a mitral valve prolapse, years ago — what was described as a heart murmur — but it was a one on a scale to ten and I didn’t have other problems, so I didn’t even think about it for years.” But in March 2020, Clemson became a member of another large community, one that he wanted no part of. “I got COVID and ended up on oxygen, 24 hours a day, seven days a week for a solid month before I was weaned off.” It was during this recovery period that Clemson focused on returning to his active lifestyle.
“I tried to get myself back in shape but started to blimp up, gaining a pound and a half every day,” Clemson said. “I had no idea how my heart valve condition could affect my overall well-being. I found I could barely move. I’ve always been very active but then things I took for granted became impossible to do. The doctors diagnosed a mitral valve prolapse. The two parts of the valves that were supposed to meet weren’t doing that, causing a leak into the other heart chamber. At first, it looked like I would need an entirely new valve but, after more study, the doctors thought I might be eligible for MitraClip.”
Loving the Science
Clemson was told that MitraClip is a small device that clips the valve leaflets together to allow them to function properly and prevent blood from flowing backward through the heart. “I loved learning about the science of the device. I was a science teacher so the more I learned about it, the better I felt,” he said.
The device is inserted through a small incision in the leg, making it a minimally invasive option that allows people to avoid open-heart surgery, a fact he greatly appreciated. The latest, fourth-generation, MitraClip offers more clip sizes for tailored repair, allowing doctors the ability to choose clip size based on each mitral valve anatomy.
MitraClip therapy has been used in 1,000 medical centers in more than 75 countries, with the device studied in more than 3,200 peer-reviewed medical journals and involving more than 60,000 patients in clinical trials. “They work hard to make these things as effective and least-invasive as possible,” Clemson said.
And he’s been happy with the results, so far. “I was released from the hospital the day after the MitraClip procedure,” Clemson said. “At first I would just go for walks. Then I would run a little. Running is part of my DNA. Then I found that I could do more. And then a bit more. Now, I’ll just go out and take in the scenery. MitraClip has helped me regain the things I value tremendously, that make my life way more fun. It’s an amazing thing.”
Almost as amazing as watching a person with mitral valve prolapse hiking, running and — yes, go ahead and check the tape — even leaping through the Nevada dessert, embracing his lifelong love of nature and fitness.
Loving the Odds of Success
It’s easy to think of Scott Clemson as a one-in-a-million success story. It is also certainly true that every patient is different and has a unique MitraClip experience. However, as the number of people who receive this therapy continues to grow in the coming years, past the populations of Alexandria, Virginia and Cambridge, UK (150,000+), past Bonn, Germany, and Nice, France (300,000+), even past San Francisco and Amsterdam (750,000+), we believe that Scott Clemson will go from being a one-in-a-million story to being part of a history in which he is one-of-a-million people in his community whose lives were improved as a result of this award-winning medical technology.
IMPORTANT SAFETY INFORMATION
MITRACLIP DELIVERY SYSTEMSINDICATION FOR USE
Rx Only
Important Safety Information
· The MitraClipTM G4 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 MitraClipTM G4 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 G4 System is contraindicated in patients with the following conditions: Patients who cannot tolerate, including allergy or hypersensitivity to, procedural anticoagulation or post procedural anti-platelet regime; Patients with known hypersensitivity to clip components (nickel / titanium, cobalt, chromium, polyester), or with contrast sensitivity; Active endocarditis of the mitral valve; Rheumatic mitral valve disease; Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus
Potential Complications and Adverse Events
The following ANTICIPATED EVENTS have been identified as possible complications of the MitraClip G4 procedure: Allergic reactions or hypersensitivity to latex, contrast agent, anaesthesia, device materials (nickel / titanium, cobalt, chromium, polyester), and drug reactions to anticoagulation, or antiplatelet drugs, Vascular access complications which may require transfusion or vessel repair including: wound dehiscence, catheter site reactions, Bleeding (including ecchymosis, oozing, hematoma, hemorrhage, retroperitoneal hemorrhage), Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation / rupture, vascular occlusion, Emboli (air thrombotic material, implant, device component); Peripheral Nerve Injury; Lymphatic complications; Pericardial complications which may require additional intervention, including: Pericardial effuse on, Cardiac tamponade, Pericarditis; Cardiac complications which may require additional interventions or emergency cardiac surgery, including: Cardiac perforation, Atrial septal defect; Mitral valve complications, which may complicate or prevent later surgical repair, including: Chordal entanglement / rupture, Single Leaflet Device Attachment (SLDA), Thrombosis, Dislodgement of previously implanted devices, Tissue damage, Mitral valve stenosis, Persistent or residual mitral regurgitation, Endocarditis; Cardiac arrhythmias (including conduction disorders, atrial arrhythmias, ventricular arrhythmias); Cardiac ischemic conditions (including myocardial infarction, myocardial ischemia, and unstable / stable angina); Venous thromboembolism (including deep vein thrombosis, pulmonary embolism, post procedure pulmonary embolism); Stroke / Cerebrovascular accident (CVA) and Transient Ischemic Attack (TIA); System organ failure: Cardio-respiratory arrest, Worsening heart failure, Pulmonary congestion, Respiratory dysfunction / failure / atelectasis, Renal insufficiency or failure, Shock (including cardiogenic and anaphylactic); Blood cell disorders (including coagulopathy, hemolysis, and Heparin Induced Thrombocytopenia (HIT)); Hypotension / hypertension; Infection including: Urinary Tract Infection (UTI), Pneumonia, Septicemia; Nausea / vomiting; Chest pain; Dyspnea; Edema; Fever or hyperthermia; Pain; Death; Fluoroscopy, Transesophageal echocardiogram (TEE) and Transthoracic echocardiogram (TTE) -related complications: Skin injury or tissue changes due to exposure to ionizing radiation, Esophageal irritation; Esophageal perforation, Gastrointestinal bleeding
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