Edwards Lifesciences Corp. (EW)’s Sapien device, inserted into the heart via a catheter to fix a diseased aortic valve, is as safe and effective as open heart surgery for as long as three years, researchers said.
The study presented at the American College of Cardiology meeting in San Francisco provides reassuring data about the device approved in the U.S. in October as the first alternative to traditional surgery. The trial, dubbed Partner, found 44.8 percent of surgery patients died within three years, compared with 44.2 percent of Sapien patients.
The study also produced favorable results for one of the most-feared complications from inserting the device: strokes. While the risk of stroke was almost double with the Sapien valve after the first year, the danger evened out over time. After three years, 8.2 percent of Sapien patients suffered a stroke, compared with 9.3 percent of the open-heart surgery patients.
“In these first-generation transcatheter procedures, we have equivalent midterm outcomes” between Sapien and the gold- standard surgical approach, said lead researcher Vinod Thourani, co-director of the Structural Heart and Valve Center at Emory University School of Medicine in Atlanta. “At three years the surgery group’s stroke rate has caught up with and slightly surpassed” the Sapien rate, though the difference wasn’t significant, Thourani said in a statement.
The risk of potentially harmful leakage around the device was significantly higher among the patients getting Sapien. An earlier analysis found patients with even mild rates of leakage had a significantly increased risk of dying, underscoring the need for improving the technology, Thourani said.
The devices are a “huge step forward” for treating damaged aortic valves, particularly for patients who might not fare well after standard open heart surgery, said Patrick O’Gara, director of clinical cardiology at Brigham and Women’s Hospital and professor at Harvard Medical School in Boston. More information is needed about how well the valves hold up over time, since those sewn into the heart to replace the aortic valve during standard surgery can last for decades, he said.
“As a community we remain appropriately concerned about some of the obstacles that need to be overcome before it can be applied to lower and lower risk patients,” O’Gara said. “Three years is a short period of time over which to make assessments about structural valve deterioration.”
The study itself will enhance doctor’s conversations with their patients and families, enabling them to discuss how the last few years of the patient’s lives will be lived, O’Gara said. The risks and benefits of each approach are becoming clearer, providing valuable information for comparison, he said.
“I don’t think anyone ever envisioned that these devices would be perfect and risk free,” he said. “After all, these are pretty sick patients with lots of reason for which things could go bad.”
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