There’s Beauty in our Latest Structural Heart Numbers

Behind the data from clinical studies of MitraClip, Navitor and TriClip is real hope for improving people’s lives.

Healthy Heart|May.22, 2023

Every day, our lives are increasingly — sometimes overwhelmingly — adrift in a sea of data.

As we use evermore advanced technology to become more efficient in our work, more productive in our free time and more expansive in our influence, it’s easy to lose sight of the true importance of all the data generated.

Because sometimes numbers are much more than just numbers.

We value the numbers because we see the beauty inherent in them. We recognize that as the digits change, so do people’s lives. With every favorable statistical increase comes a corresponding rise in the number of guests at holiday dinners, in birthday cards received and in smiles populating family photos.

These are the numbers our Structural Heart business works so hard to improve. The ones that support the safety and effectiveness of our innovative products. We understand the future of structural heart care has never been more promising and are committed to leading the way.

Studying the Studies

A series of recently published studies, for instance, produced valuable data showing how effective several of our Structural Heart products have been in treating serious cardiac conditions.

One of the most pressing of those conditions is mitral regurgitation (MR). It is the most common type of heart valve disease, occurring when the valve between the left heart chamber doesn't close completely, allowing blood to leak backward across the valve. If the leakage is severe, not enough blood will move through the heart or to the rest of the body. As a result, MR can make you feel very tired or short of breath.

Our MitraClip transcatheter edge-to-edge repair (TEER) device offers a minimally invasive mitral valve repair in advanced heart failure patients and was the subject of a study showing new five-year data presented at the American College of Cardiology’s 72nd Annual Scientific Session together with World Congress of Cardiology, reinforcing the long-term safety and effectiveness of MitraClip for treating secondary MR.

After five years of patient follow-up, data from the study demonstrated substantial benefits for patients, including confirmation that MitraClip therapy:

  • Significantly reduced the risk of annualized hospitalizations by nearly half (33% per year vs. 57% in the control group),
  • Reduced the risk of death by almost 30% (57% vs. 67% in the control group),
  • Achieved durable MR reduction, with 95% of patients experiencing reduced MR from moderate-to-severe or severe (grade ≥ 3+ on a four-point scale) to mild or moderate (grade ≤ 2+).

Patients in the study received the first-generation MitraClip, the world's first transcatheter edge-to-edge repair (TEER) device. Since the introduction of MitraClip two decades ago, there have been advances in the device, with the fourth generation of the technology currently on the market, all proven to be safe and reduce MR further.

Navigating the Navitor Numbers

Additional exciting data came recently in the form of results presented at Cardiovascular Research Technologies (CRT) 2023,  that demonstrated the safety of our next-generation Navitor transcatheter aortic valve implantation (TAVI) system and its effectiveness in minimizing blood leakage around the valve implant.

Results from the study supported Navitor's recent U.S. approval to treat people with severe, symptomatic aortic stenosis who are at high or greater risk for open-heart surgery. Navitor features the active sealing NaviSeal Cuff to reduce the backflow of blood around the valve (known as paravalvular leak, or PVL).

The device is designed to help open a narrowed aortic valve in people with severe aortic stenosis, one of the most common and life-threatening heart valve diseases. It gives physicians another minimally invasive option for those at high or extreme risk for open-heart surgery complications.

Again, the data paints a beautiful picture that shows more than mere numbers generated. Feast your eyes on these:

  • High rate of procedural success (97%).
  • Low rate of all-cause mortality (1.9%) and disabling stroke (1.9%) at 30 days.
  • Excellent PVL results, including 0% moderate or greater PVL at 30 days.

Tallying the TriClip Totals

One serious cardiac condition that we have been helping people battle is tricuspid regurgitation (TR), a type of heart valve disease in which the valve between the two right heart chambers (right ventricle and right atrium) doesn't close properly. As a result, blood leaks backward into the upper right chamber (right atrium).

recent Abbott study presented at EuroPCR 2023, the annual meeting of the European Association of the Percutaneous Cardiovascular Interventions, provided data that adds to the body of clinical evidence supporting the benefits of our TriClip transcatheter edge-to-edge repair system (an investigational device in the U.S.) in treating patients with TR. 

The bRIGHT study, the largest real-world dataset for transcatheter tricuspid valve repair, supports the safety and effectiveness of the TriClip system in patients with leaky tricuspid valves.

What about the numbers, you ask? Excellent question, with these results through 30 days standing out:

  • There was a significant reduction of TR grade to moderate or less for 77% of the patients.
  • There were significant clinical and quality of life improvements in quality of life, with 79% of participants achieving New York Heart Association (NYHA) Functional Class I/II (meaning they reached a point of slight or no limitation of physical activity), a nearly 60% improvement from the baseline proportion of 20%. In addition, more than half (56%) of patients reported a 15-point improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score (a self-assessment of symptoms, physical and social limitations, and quality of life), representing a substantial improvement in quality of life and health status.
  • And significantly, there was a strong safety profile. Only 2.5% of patients who received the device experienced a major adverse event, a composite of cardiovascular death, heart attack, stroke, new onset of kidney failure and surgery for device-related adverse events.

The People Beyond the Numbers

While numbers are beautiful, too many can be dizzying and overwhelming -- not unlike heart disease itself. We get that. Which is why, although we work nonstop to make that data as strong as it can be, we also look beyond the facts and figures to the picture that truly reflects our focus.

People like Scott.

Our entire Structural Heart portfolio of products is designed to help people like Scott, Cruz, Colby, Irie, Alan, Derek, Gareth, Jozef and many more around the world be the face of Abbott science, the strength behind the numbers and the beauty of the data.





The MitraClip™ 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 MitraClip™ 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.


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


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



The Navitor™ Transcatheter Aortic Valve Implantation System is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical comorbidities unmeasured by the STS risk calculator).


The valve is contraindicated for patients with inability to tolerate antiplatelet/anticoagulant therapy or nitinol alloy (nickel and titanium), or who have active infections, including endocarditis.


Adverse events potentially associated with the use of transcatheter bioprosthetic heart valves include but are not limited to: access site complications (e.g., pain, bleeding, infection, hematoma, pseudoaneurysm, etc.); acute coronary obstruction; acute myocardial infarction; allergic reaction to antiplatelet agents, contrast medium, or valve components; aortic rupture; ascending aorta trauma; atrio-ventricular node block; cardiac arrhythmias; conduction system injury; conversion to open surgical procedure; death; dissection; embolism; emergent balloon valvuloplasty; emergent percutaneous coronary intervention (PCI); emergent surgery (i.e., coronary artery bypass, heart valve replacement); endocarditis; explanation; heart failure; hemodynamic compromise; hemolysis; hemolytic anemia; hemorrhage; hypotension or hypertension; infection; myocardial ischemia; mitral valve insufficiency; multi-organ failure; non-structural dysfunction (i.e., entrapment by pannus, paravalvular leak, inappropriate sizing or positioning); pannus; pericardial effusion; perforation of the myocardium, ventricle, or a blood vessel; permanent disability; permanent pacemaker; regurgitation; renal insufficiency or renal failure; reoperation; respiratory failure; sepsis; stroke; structural deterioration (i.e., calcification, leaflet tear); thrombosis; tamponade; transfusion; valve embolization or migration; vessel dissection or spasm.