Avoiding surgery for early breast cancer

Hello Health Rounds readers! Today we feature a pair of potentially practice-changing studies - one that found many women with certain early invasive breast cancers may be able to avoid surgery, and another that found no benefit from a widely used device after heart valve replacement. We also highlight a novel experimental pacemaker that could be just the thing for infants with heart defects.

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Patients with early-stage invasive breast cancer can safely skip surgery if the tumors disappear after chemotherapy, a small new study suggests.

Thirty-one patients with no evidence of residual cancer after chemotherapy for small, invasive HER-2 positive or triple-negative tumors all received radiation therapy, but none had surgery.

Five years later, all 31 were still alive, with no recurrence of the cancer, researchers reported at the Society of Surgical Oncology 2025 Annual Meeting in Tampa, Florida and in JAMA Oncology.

"The absence of detectable breast cancer recurrences at the five-year mark highlights the tremendous potential of this surgery-free approach to breast cancer management," study leader Dr. Henry Kuerer of The University of Texas MD Anderson Cancer Center said in a statement.

He attributes the success to use of a particularly accurate biopsy method to check for residual disease after chemo. During image-guided vacuum assisted biopsy, his team used ultrasound or magnetic resonance imaging to achieve more accurate needle placement and to collect multiple tissue samples with a single insertion.

The researchers have expanded the trial to include more women, Kuerer noted.

"These continued promising results suggest that eliminating breast surgery for invasive breast cancer could become the new standard of care, offering women the opportunity to preserve their bodies," he said.

"While we are hopeful that this approach will become routine, further clinical trials are necessary before this is a standard therapy."

An experimental cardiac pacemaker smaller than a grain of rice can be inserted with a syringe and activated by light, and it dissolves when no longer needed, researchers reported in Nature.

Although it can work with hearts of all sizes, the pacemaker is particularly well-suited to the tiny hearts of newborn babies with congenital heart defects, the researchers said.

The pacing is controlled by a small, soft, flexible, wireless, wearable device on the patient's chest. When the device detects an irregular heartbeat, it automatically shines a light pulse through the patient's skin, breastbone and muscles to activate the pacemaker.

Designed for patients who only need temporary pacing, the pacemaker has biocompatible components that naturally dissolve into body fluids.

Researchers have so far tested the device in large and small animals and in human hearts from deceased organ donors.

Infants who undergo surgery for congenital heart defects only need pacemakers for about seven days, until the heart recovers, study leader Igor Efimov of Northwestern University in Evanston, Illinois noted in a statement.

"But those seven days are absolutely critical," Efimov said.

Ultimately, he said the hope is, "we can place this tiny pacemaker on a child's heart and stimulate it with a soft, gentle, wearable device. And no additional surgery is necessary to remove it."

A widely used device for protecting against stroke after minimally invasive heart valve replacement procedures failed to show any benefit in a large clinical trial, researchers reported at the American College of Cardiology Annual Scientific Session in Chicago.

The device – the Sentinel Cerebral Protection System from Boston Scientific – is designed to filter fragments of tissue that can be released into the bloodstream when doctors insert a new heart valve via an artery in the arm or the groin, in a procedure called transcatheter aortic valve replacement, or TAVR.

If these embolic fragments are not caught, they can travel to the brain and cause strokes.

But among 7,635 UK patients treated by TAVR between 2020-2024 at an average age of 81, there was no difference in stroke rate at 72 hours after the procedure regardless of whether participants were randomized to undergo TAVR with the Sentinel device or without such protection, researchers found.

Stroke rates were 2.1% in the Sentinel group and 2.2% in the control group.

There was also no difference between the groups in rates of death from any cause, stroke severity, disabling stroke and cognitive outcomes, according to a report of the trial published in The New England Journal of Medicine.

Sentinel is the most frequently used embolic protection device in TAVR procedures, the researchers said.

Study leader Dr. Rajesh Kharbanda of the University of Oxford said the trial was large enough and appropriately designed to address the question of whether the Sentinel Cerebral Protection System is effective in these patients.

"Our study provides convincing evidence that there is no value in the routine use of this device during (TAVR)," he said.

Boston Scientific told Reuters that an upcoming analysis of 10,000 patients from this and an earlier trial with similar results to be presented at a medical meeting next month may help  identify subgroups of patients that might benefit from Sentinel.

This newsletter was edited by Bill Berkrot; additional reporting by Shawana Alleyne-Morris.

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