Study supports fixing heart valves without surgery

NEW ORLEANS — Cardiologists are reporting a major advance: A long-awaited study suggests that many people with a bad aortic valve, the heart’s main gate, can avoid open-heart surgery and have a new one placed through a tube in an artery instead.

There is a downside — a higher risk of stroke — and uncertainty about how long these valves will last.

Still, doctors predicted that if the new valve wins federal approval, patients would embrace it as they did balloon angioplasty, which has allowed millions to have clogged arteries fixed without an operation.

“The fact that it’s not open-heart surgery sells itself, and the rest gets lost in the mix,” said Dr. Craig Smith, heart surgery chief at Columbia University and New York-Presbyterian Hospital.

He led the study and gave results Sunday at an American College of Cardiology conference in New Orleans.

Dr. Michael Crawford, chairman of the meeting and cardiology chief at the University of California, San Francisco, called it “a historic event” that would dramatically change practice. “As good as surgery is, patients just don’t want it,” he said.

The aortic valve can stiffen and narrow with age, making the heart strain to push blood through it. Severe cases are treated with surgery to replace the valve, but that’s risky for many older people who have this problem. Without an operation, half die within two years.

The study tested a way to wedge in a new valve without surgery. Dr. Edward McNulty, a cardiologist at the University of California, San Francisco, explained how it works:

Through an artery in the groin or the chest, “a new heart valve is literally crimped on a balloon and advanced across the narrowed, older, diseased heart valve. The balloon is inflated and the new valve left in place.”

A test of this gentler approach in people too sick for surgery found it greatly improved survival, doctors reported last fall. The new study involved nearly 700 people eligible but at high risk for surgery.

Their median age was 84, and they were randomly assigned to get valves replaced through surgery or the new way. Here’s how much people dread this operation: 28 people withdrew from the study or refused treatment once they learned they had been placed in the surgery group.

In the end, both groups did very well.

After one year, about 24 percent of the artery patients and 27 percent of the surgery patients had died — comparable results in a study this size and considerably fewer than researchers had predicted.

However, strokes and other neurological problems were twice as common in the artery-treated group — 8 percent versus 4 percent. Previous studies also found more strokes with the artery approach.

Other complications were a trade-off: Major bleeding and new cases of a fluttering heartbeat called atrial fibrillation were more common after surgery; there were more blood-vessel problems with the artery approach.

Leakage was more common with the new-style valve, too, though doctors said that problem can get better with time.

“It will take longer to figure that out,” Smith said.

The valve’s maker, Edwards Lifesciences Corp. of Irvine, Calif., paid for the study, and some researchers consult for the company. Edwards is seeking federal approval to sell the valve for inoperable patients now, and plans to ask the same for less ill patients like those in the new study in a few months.

The company plans to charge $30,000 for the valve, which is already used in Europe. Another study presented Sunday on the first group of patients treated with it — those too sick for surgery — put the total cost with doctor fees and hospitalizations at $73,563.

However, in those patients, it proved cost-effective — costs were higher for hospitalizations of people who did not get new valves.

Doctors caution that these are only one-year results, and it will take at least five years of study to know whether these less invasive treatments will be as good as surgically implanted valves that typically last 20 years.

Having this option available for people too sick to have surgery would be great, but it’s too soon to say if it should be used in less sick patients, said Dr. Elliott Antman, a Brigham and Women’s Hospital cardiologist and American Heart Association spokesman.

Yet there is a big unmet need — about 30 to 40 percent of people with very bad aortic valves are not being referred for surgery now, “and not all of them are patients that are inoperable,” said Dr. Ralph Brindis, a California cardiologist who is president of the cardiology college.

Charles Cohen, who will be 90 in August, got an artery-placed valve two years ago at Cedars-Sinai Medical Center in Los Angeles, where he lives, as part of the study.

“I was a little bit leery” of either option, but was hoping for the catheter. Before he had it, he could walk only a block or so before having to stop to rest. “Now I walk half a mile,” he said.

Talk to us

> Give us your news tips.

> Send us a letter to the editor.

> More Herald contact information.

More in Local News

Customers enter and exit the Costco on Dec. 2, 2022, in Lake Stevens. (Olivia Vanni / The Herald)
Costco stores could be impacted by looming truck driver strike threat

Truck drivers who deliver groceries and produce to Costco warehouses… Continue reading

Two Washington State ferries pass along the route between Mukilteo and Clinton as scuba divers swim near the shore Sunday, Oct. 22, 2023, in Mukilteo, Washington. (Ryan Berry / The Herald)
Ferry system increases ridership by a half million in 2024

Edmonds-Kingston route remains second-busiest route in the system.

Firefighters respond to a 911 call on July 16, 2024, in Mill Creek. Firefighters from South County Fire, Tulalip Bay Fire Department and Camano Island Fire and Rescue left Wednesday to help fight the LA fires. (Photo provided by South County Fire)
Help is on the way: Snohomish County firefighters en route to LA fires

The Los Angeles wildfires have caused at least 180,000 evacuations. The crews expect to arrive Friday.

x
Edmonds police shooting investigation includes possibility of gang violence

The 18-year-old victim remains in critical condition as of Friday morning.

The Everett Wastewater Treatment Plant along the Snohomish River. Thursday, June 16, 2022 in Everett. (Olivia Vanni / The Herald)
Everett council approves water, sewer rate increases

The 43% rise in combined water and sewer rates will pay for large infrastructure projects.

Robin Cain with 50 of her marathon medals hanging on a display board she made with her father on Thursday, Jan. 2, 2025 in Lake Stevens, Washington. (Olivia Vanni / The Herald)
Running a marathon is hard. She ran one in every state.

Robin Cain, of Lake Stevens, is one of only a few thousand people to ever achieve the feat.

People line up to grab food at the Everett Recovery Cafe on Wednesday, Dec. 4, 2024 in Everett, Washington. (Olivia Vanni / The Herald)
Coffee, meals and compassion are free at the Everett Recovery Cafe

The free, membership-based day center offers free coffee and meals and more importantly, camaraderie and recovery support.

Devani Padron, left, Daisy Ramos perform during dance class at Mari's Place Monday afternoon in Everett on July 13, 2016. (Kevin Clark / The Herald)
Mari’s Place helps children build confidence and design a better future

The Everett-based nonprofit offers free and low-cost classes in art, music, theater and dance for children ages 5 to 14.

The Everett Wastewater Treatment Plant along the Snohomish River on Thursday, June 16, 2022 in Everett, Washington. (Olivia Vanni / The Herald)
Everett water, sewer rates could jump 43% by 2028

The rate hikes would pay for improvements to the city’s sewer infrastructure.

The bond funded new track and field at Northshore Middle School on Thursday, Oct. 24, 2024 in Bothell, Washington. (Courtesy of Northshore School District)
Northshore School District bond improvements underway

The $425 million bond is funding new track and field complexes, playgrounds and phase one of two school replacements.

The Everett Municipal Building on Thursday, Feb. 29, 2024 in Everett, Washington. (Annie Barker / The Herald)
Everett council approves $111 million construction of sewer project

The Port Gardner Storage Facility, in the works for more than a decade, will help prevent overflows of the city sewer system.

Two students walk along a path through campus Thursday, Aug. 4, 2022, at Everett Community College in Everett, Washington. A group of nearly 20 community groups are planning to study how to make it easier for young people to find jobs. (Ryan Berry / The Herald)
Goal for Everett coalition: Make it easier for young people to find jobs

The organizations hope the months-long process will improve access to resources for young people.

Support local journalism

If you value local news, make a gift now to support the trusted journalism you get in The Daily Herald. Donations processed in this system are not tax deductible.