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Photo (LTR): Dr. Christian Spies, Dr. David Daniels, Dr. Mark Lebehn, Dr. Bob Bellerose

Clinical research at Sutter is advancing real-world care for mitral valve disease.

When a multidisciplinary heart care team at Sutter’s California Pacific Medical Center (CPMC) gathered early one morning last month, they were preparing to deliver a new option for patients living with severe mitral valve disease.

The team was set to perform one of the first commercial transcatheter mitral valve replacement (TMVR) procedures in the United States using Edwards Lifesciences’ SAPIEN M3™ system, a new therapy approved by the U.S. FDA Dec. 23 for real-world care.

Led by cardiologist Dr. David Daniels, structural heart section chief for Sutter Health’s Advanced Heart & Vascular Service Line and national principal investigator of the pivotal ENCIRCLE trial, the team successfully completed two TMVR procedures in a single morning. They also marked another milestone – together, the cases represented some of the most streamlined SAPIEN M3™ TMVR procedures performed to date.

“It’s incredibly gratifying to see this innovative therapy move from research into real-world care,” says Dr. David Daniels. “The fact that our first commercial cases at Sutter were also among the most efficient performed to date speaks to the expertise and precision of our team. More importantly, it illustrates what’s now possible for patients who once had very limited treatment options. It truly feels like science fiction that both of these patients were successfully treated in 30 minutes each from start to finish with a fully percutaneous mitral valve replacement.”

Dr. Daniels notes he has been involved with this technology since its earliest days, when procedures could take hours. “To witness the evolution of this therapy and to help bring forward what’s possible in cardiac care is an immense honor,” he says. “I’m truly grateful to be part of this work.”

Expanding Options for Complex Mitral Valve Disease

The SAPIEN M3™ system is the first transcatheter mitral valve replacement therapy in the United States to use a transseptal approach. It is approved for patients with significant mitral regurgitation or mitral valve dysfunction who are not candidates for surgery or transcatheter edge-to-edge repair.

For decades, many of these patients had few or no viable options. Now, TMVR allows physicians to replace the mitral valve through a small catheter inserted through the femoral vein, avoiding open-heart surgery and often shortening recovery

“This technology represents a major step forward for a group of very sick patients with no other option,” says Dr. Matthew Solomon, vice president and chief scientific officer at Sutter Health. “Our physician-researchers and cardiovascular care teams have worked side-by-side to bring this therapy from clinical trials to everyday practice. That collaboration and relentless commitment to clinical excellence are exactly what accelerate innovation across Sutter.”

The CPMC team included Dr. Daniels, Dr. Christian Spies, Dr. Mark Lebehn and anesthesiologist Dr. Bob Bellerose, along with a highly skilled nursing, imaging and cardiac catheterization lab team supporting the effort.

“Our structural heart teams are committed to delivering complex care with the highest level of safety, coordination and compassion,” says Dr. Michael Pham, chair of Sutter’s Advanced Heart & Vascular Service Line. “Moments like this highlight the training, trust and teamwork – including close collaboration with industry partners like Edwards Lifesciences – it takes to bring groundbreaking therapies to patients who need them most.”

Read Sutter patient’s Karine Gasparyan’s story here.

Clinical Research Driving Real-World Impact

The one-year ENCIRCLE pivotal trial, published in The Lancet, demonstrated that 95.7% of patients treated with the SAPIEN M3™ transcatheter mitral valve replacement system achieved near-complete elimination of mitral regurgitation with meaningful improvement in symptoms and quality-of-life.

Sutter’s Dr. Daniels played a key role in the research that helped make FDA approval possible, and now its clinicians are among the first to bring this therapy into clinical care.

“For our patients, it’s all about access to having the latest therapies. This progress in care will directly impact how they feel and function. It will mean greater energy, less limitation and more freedom in their daily life, and that’s huge,” says Dr. Daniels.

Looking Ahead

As adoption of TMVR grows, Sutter’s structural heart teams will continue advancing minimally invasive therapies for complex valve disease, grounded in research, collaboration and patient-centered care.

Find heart and vascular care close to home and join clinical trials at Sutter for those eligible. 

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WASILLA – An upcoming project will install medians along the middle of the Parks Highway on the west side of Wasilla, blocking most left turns from the center lane and lengthening a stop light turn lane on Palmer-Wasilla Highway Extension heading toward Home Depot, state and city officials said last month.

The update also includes extending a right-turn lane at the Palmer-Wasilla Highway stop light below Home Depot to allow more space for vehicles turning right onto the Parks Highway away from Wasilla, they said.

Officials said the projects are intended to reduce collisions and improve traffic flow near the Parks and Palmer-Wasilla Highway intersection.

The area has been the site of dozens of vehicle accidents since 2018, including at least four that resulted in a fatality or serious injury, according to Matanuska-Susitna Borough accident data. About 38,000 vehicles travel the thoroughfare each day, according to state traffic data.

Work on the $3.5 million project could start this summer but will likely continue into 2027, transportation officials said.

Crews will add a median blocking left turns over about 1.5 miles between the Parks and Palmer-Wasilla Highway intersection and Broadview Avenue, officials said. A pre-existing median near the Palmer-Wasilla Highway intersection will be updated to eliminate a left-hand turn into MATCOM or from the Target shopping area.

The median will include new turn pockets at designated intervals to allow for some left turns across oncoming traffic in certain locations, they said. No new turn signals are planned.

Exactly where those turn areas will be placed will be determined through a traffic analysis, said Chris Bentz, a Department of Transportation project manager.

“We’re going to evaluate during the course of this effort to figure out what we can do to, firstly, reduce the amount of left-turning traffic with the median. But secondly, where will it be prudent to maintain some amount of left turn?” he said.

Known for its mile-long evening rush hour backup, collisions and vehicle standoffs in the center two-way lane as drivers attempt to make offset left turns, the corridor is also the center of rapid business growth. A new 107-room Hilton Home2 Suites hotel is expected to open in the area in 2027, the first national hotel chain to open a new property in the Mat-Su in decades.

That growth means the traffic problems must be addressed now, said Wasilla City Council member Ian Crafton, who proposed a resolution in late 2024 requesting that the state tackle the project.

The changes will ultimately force shoppers to alter how they enter and exit some businesses along the corridor – including Lowe’s, Evangelos, and the Sun Mountain Shopping Center – changes that are likely to cause heartburn among some of the area’s business owners, Crafton said.

“I’m hoping we’re going to minimize the access to these businesses, and really the goal here is safety,” he said. “Sometimes that means road changes we could not foresee. Nobody knew this was going to grow like this.”

Traffic along the area may eventually also be eased by a separate project to extend Herman Road from where it starts near Lowe’s north to connect with the Palmer-Wasilla Highway. Construction on that project is expected to start in 2027, according to a state fact sheet.

How traffic flows along the Sun Mountain frontage road and through the series of three-way stop signs will be addressed in a future project, Bentz said. Those intersections are also the site of regular collisions, according to borough traffic data.

This story originally appeared in the Mat-Su Sentinel and is republished here with permission.