Medtronic Inc.’s CoreValve, a device threaded into the heart via a catheter and expanded to repair a damaged aortic valve, dramatically improved symptoms without causing excessive cardiovascular complications after one year.
A study of 806 patients showed 13 percent had moderate to severe symptoms after treatment for calcification to a valve that sits between the heart’s main pumping chamber and the artery that carries oxygen-rich blood to the body. A year earlier, 80 percent of the participants had the symptoms, which included fatigue that limited physical functioning, according to the findings presented today at the EuroPCR meeting in Paris.
Patients in the study known as Advance were considered at high risk from dying if they underwent traditional, open-heart surgery to fix the damage. A separate analysis also found that the cost of the procedure and the device, called transcatheter aortic implant, or Tavi, is significantly less than many other treatments, Minneapolis-based Medtronic said in a statement.
“We know that these interventions are expensive, and we sometimes wonder if they are worthwhile,” said Stephen Brecker, a researcher and cardiologist from St. George’s Hospital in London who presented the findings. “Now we have evidence that Tavi with CoreValve represents good value for health-care spending in terms of additional quality and quantity of life.”
Patients in the trial received the CoreValve at one of 44 centers in 12 countries in Western Europe, Asia and South America. Heart attack, stroke, retreatment or death occurred in 21.2 percent of patients after one year. Major bleeding occurred in 11 percent of patients, and 1 in 5 needed a pacemaker.
Regurgitation, where the blood flows backward, occurred at a moderate level in 13 percent of patients getting the device, the study found. The risk didn’t boost death rates, as seen in studies of rival devices. Moderate leakage around the valve developed in 12 percent of patients within a month and remained stable after one year, with no severe leakage.
A second-generation rival valve from Edwards Lifesciences Corp., Sapien XT, posted one-year survival rates of 81 percent in its own registry. Strokes occurred in 6.3 percent of patients, while regurgitation developed in 6.2 percent, according to the analysis of 2,688 patients treated at 93 centers in Europe.
The findings eased concern that the Sapien XT could allow blood to flow backward, a factor that has been linked to higher death rates.
The results from the two studies weren’t directly comparable. The patients in the Edwards study were sicker than those in the Medtronic trial, including some who wouldn’t have qualified for traditional surgery. They also received the Sapien XT valve via four approved methods, including directly into the heart via an incision between the ribs and under the collarbone.
Medtronic, which also reported fiscal fourth-quarter profit that beat analyst estimates today, rose 4.9 percent to $52.35 at the close in New York, the biggest one-day gain since August 2011. The shares have increased 39 percent in the past 12 months. Edwards shares fell less than 1 percent to $66.
A separate analysis of Medtronic’s study presented at the meeting found treatment, including the operation, the device and hospital stay, cost 7,700 pounds ($11,750) for every additional year of life it granted.
Medtronic’s CoreValve and Edwards’ Sapien XT are both sold in Europe. They are in clinical testing needed to win clearance in the U.S. from the Food and Drug Administration.