Minimally invasive treatment demonstrates sustained improvement for heart valve patients with limited options

Findings from the AltaValve Early Feasibility Study suggest that patients with a leaky mitral valve have sustained clinical benefits one year following atrial fixation Transcatheter Mitral Valve Replacement (TMVR). Researchers presented the late-breaking data at the Society for Cardiovascular Angiography & Interventions (SCAI) 2026 Scientific Sessions & Canadian Association of Interventional Cardiology/Association Canadienne de cardiologie d’intervention (CAIC-ACCI) Summit in Montreal.

Mitral regurgitation (MR) occurs when the mitral valve, a flap that regulates blood flow between the heart’s left chambers, does not close properly, causing blood to leak back into the heart instead of toward the rest of the body. MR is one of the most common heart valve diseases, affecting more than 175 million people worldwide and around five million Americans.

Patients over 75 who do not receive treatment have a 50% chance of death at five years, yet some, particularly those with smaller valve anatomy or a hardened valve, are not qualified for typical surgical or transcatheter treatments.

For those with no care options, atrial-fixation TMVR is an emerging minimally invasive technique that places a prosthetic valve above the original, diseased valve to reduce the risk of a blood flow blockage, called a left ventricular outflow tract (LVOT) obstruction, or strain on the surrounding heart tissue.

The AltaValve Early Feasibility Study is a prospective, multicenter, single-arm study that evaluated the safety and performance of the AltaValve System (4C Medical Technologies Inc.). Researchers included 30 patients with symptomatic (≥3+) MR who were determined as high surgical risk or unsuitable for other transcatheter therapies due to anatomy.

The study population was 63% female, with a mean age of 77.0 ± 6.2 years. Thirteen subjects were treated through a transapical approach (through the ribs) and 17 through a transseptal approach (through the femoral vein), as determined by the patient’s peripheral blood vessel health. Safety, performance, functionality, and quality of life outcomes were assessed at baseline, discharge, 30-day, six-month, and one-year follow-up.

Results found that atrial-fixation TMVR reduced MR in almost all cases (97%). One year post-intervention, TMVR reduced and maintained MR to mild severity in 95% of patients, resulting in little to no discomfort when participating in physical activity.

Heart ultrasound results found treatment sustained the percentage of blood pumped by the left ventricle per beat (53% at one year vs. 54% at baseline), along with the average pressure across the mitral valve (4.0 mmHg) and LVOT (1.8 mmHg).

Functional outcomes also improved, with the six-minute walk test increasing by 43 meters on average. There were no instances of complications like stroke, device migration, new atrial fibrillation, life-threatening bleeding, or need for pacemaker replacement.

“This is the first time we are presenting the durability and hemodynamic assessment of atrial-fixation TMVR performance at one-year follow-up, providing us with qualitative data on valve performance,” said Konstantinos Voudris, MD, Ph.D., FSCAI, Minneapolis Heart Institute, Abbott Northwestern Hospital in Minneapolis.

“Our findings suggest excellent valve performance, sustained positive outcomes, and a low rate of complications, as health benefits did not taper off at one year post-TMVR. We hope this can become a durable, efficient, and therapeutic option for a broad patient population with limited treatment options.”

Findings from this study are now being further validated in the statistically powered ATLAS Pivotal Trial.