MDT Medtronic PLC

By Jeanne Whalen 

A minimally invasive procedure to repair diseased heart valves delivered about the same health outcomes for patients as open-heart surgery, a result doctors say could widen use of the new procedure.

The study, published in the New England Journal of Medicine and set for presentation Friday at the American College of Cardiology's annual meeting, compared the procedures in patients with aortic stenosis, a common disorder where blood flow from the heart is restricted due to narrowing of the aortic valve opening.

In the minimally invasive procedure, an artificial valve made by Medtronic PLC was fed to the patients' hearts through a tube inserted into a large artery in the groin. The procedure is known as transcatheter aortic valve replacement, or TAVR. Patients in the other group received whatever artificial valve the surgeon deemed appropriate, via open-heart surgery.

The 1,746 patients selected for the trial were judged to have a 3% to 15% chance of dying within 30 days if they underwent open-heart surgery, a range surgeons deem an "intermediate risk." The minimally invasive procedure is already widely performed in patients who would have a higher risk of dying after surgery. It has been less scrutinized in lower-risk patients.

Medtronic funded the trial and supplied its artificial valves, called CoreValve and Evolut R, for use in the TAVR patients. The company said it has submitted the trial results to the Food and Drug Administration and requested permission to market its valves for use in intermediate-risk patients. The FDA last year gave competitor Edwards Lifesciences permission to sell its valves for intermediate-risk patients.

The main goal of the Medtronic study was to track the number of patients who died from any cause or had a disabling stroke after 24 months. The results presented Friday were from a planned interim analysis based on the number of deaths and strokes reported after most of the patients had been followed for 12 months. The researchers used this data to project the likely results after 24 months. The trial continues and will include a final analysis after all patients are followed for 24 months.

The interim results showed that TAVR and open-heart surgery produced about equal results. The estimated incidence of death or disabling stroke at 24 months in the TAVR group was 12.6%, versus 14% in the open-heart surgery group, a difference that wasn't statistically significant, meaning it could have been due to chance. The mean age of patients in the trial was 80.

TAVR's benefits over surgery include more rapid recovery for the patient, and the lack of anesthesia needed to perform the procedure, according to Michael Reardon, a leader of the study and professor of cardiothoracic surgery at Houston Methodist DeBakey Heart & Vascular Center. Patients are sedated but remain awake during the procedure, and are typically out of bed and walking around the same day, he said. One month after their procedures in the study, patients who underwent TAVR reported higher quality-of-life scores than surgery patients did, he said.

The procedures were associated with different adverse events. Patients in the open-heart surgery group had a greater need for blood transfusions, and higher rates of acute kidney injury and irregular heartbeat known as atrial fibrillation. Patients in the TAVR group were more likely to have leaks from their artificial valves. They also required the implantation of pacemakers more frequently -- 25.9% of patients in the TAVR group needed them, versus 6.6% in the surgery group -- because the TAVR procedure was more likely to damage tissue that helps transmit the heart's natural electrical signals, according to Robert Bonow, a cardiology professor at Northwestern University's Feinberg School of Medicine, who wasn't involved in the trial.

Dr. Bonow said the need for pacemakers with TAVR "does raise some issues as we evolve the technology into younger and less sick people." Still, he said the cardiology field is already shifting to performing more TAVR procedures in intermediate-risk patients.

This week, new treatment guidelines published by the ACC and American Heart Association for the first time deemed TAVR as equally suitable for intermediate-risk patients as surgery, according to Dr. Bonow, who co-wrote the guidelines.

Samir Kapadia, a cardiologist at the Cleveland Clinic, said he found it "comforting" to see in the study results that "with a minimally invasive procedure you can achieve as much as you can with surgery." He wasn't involved in the study.

Write to Jeanne Whalen at jeanne.whalen@wsj.com

(END) Dow Jones Newswires

March 17, 2017 09:14 ET (13:14 GMT)

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