左室辅助设备延长晚期心力衰竭患者的生命
WESTPORT, CT (Reuters Health) - In patients with chronic end-stage heart failure for whom heart transplantation is not an option, a left ventricular assist device can prolong survival compared with optimal medical management. The device also appears to significantly improve patients' quality of life.
These findings from a 3-year, 22-center trial, which will be published in the November 15th issue of The New England Journal of Medicine, were released Monday to coincide with the investigators' presentation at the American Heart Association's Scientific Sessions 2001 in Anaheim, California.
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Dr. Eric A. Rose, of Columbia University in New York City, and members of the Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) study group enrolled adult patients who, because of age or a clinically significant condition, were not suitable candidates for transplantation.
Between 1998 and 2001, 68 patients were randomly assigned to have a HeartMate vented electric left ventricular assist device (Thoratec, Pleasanton, California) surgically implanted. The remaining 61 patients received optimal medical management.
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After 1 year of followup, survival was 52% in the device group and 25% in the medical therapy group (p = 0.002). At 2 years, the rates were 23% and 8%, respectively (p = 0.09). Patients who received a device survived for a median of 408 days, compared with 150 days in the other group.
The most common cause of death was terminal heart failure in the medical therapy group. Those who received the device were more prone to dying from sepsis and device failure. Quality of life scores were significantly better in the device group at 1 year, even though patients with a device were at more than double the risk of a serious adverse event during followup compared with medically managed patients.
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For patients in the device group, "the timing of adverse events was scattered throughout their course," Dr. Rose told Reuters Health. "Many had an adverse event who did better after their adverse event, particularly the early postoperative bleeding issues and neurological dysfunction. In past generations, virtually everyone on a device like this had a stroke. That was clearly not the case in this study, where only about 10% of the patients on a device did."
In the journal paper, the investigators express the hope that, in addition to improving care for patients with end-stage heart failure, such devices will become a viable therapy for patients with less severe heart-failure syndromes. "Even lesser degrees of heart failure are still mortal illnesses," Dr. Rose said. "The quality of life of those patients is still severely impaired."
, http://www.100md.com
He added that with the aid of devices such as HeartMate, patients could even expect to return to work. "The results in REMATCH in the 22 patients less than 60 years of age were absolutely stunning. The 74% one-year survival brings it up almost to the performance of transplantation," Dr. Rose pointed out.
Thoratec announced that it has submitted data from this trial to the US Food and Drug Administration, seeking a new indication for HeartMate. If approved, it would be the first ventricular assist device indicated for end-stage heart failure.
, 百拇医药
"Technology will ultimately solve many of the problems involved in applying mechanical cardiac support therapy to a wide spectrum of patients with heart failure," Dr. Mariell Jessup, of the Hospital of the University of Pennsylvania in Philadelphia, predicts in an editorial. She points out, however, that the cost per year of life gained may be too much for society to bear., http://www.100md.com
These findings from a 3-year, 22-center trial, which will be published in the November 15th issue of The New England Journal of Medicine, were released Monday to coincide with the investigators' presentation at the American Heart Association's Scientific Sessions 2001 in Anaheim, California.
, http://www.100md.com
Dr. Eric A. Rose, of Columbia University in New York City, and members of the Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) study group enrolled adult patients who, because of age or a clinically significant condition, were not suitable candidates for transplantation.
Between 1998 and 2001, 68 patients were randomly assigned to have a HeartMate vented electric left ventricular assist device (Thoratec, Pleasanton, California) surgically implanted. The remaining 61 patients received optimal medical management.
, http://www.100md.com
After 1 year of followup, survival was 52% in the device group and 25% in the medical therapy group (p = 0.002). At 2 years, the rates were 23% and 8%, respectively (p = 0.09). Patients who received a device survived for a median of 408 days, compared with 150 days in the other group.
The most common cause of death was terminal heart failure in the medical therapy group. Those who received the device were more prone to dying from sepsis and device failure. Quality of life scores were significantly better in the device group at 1 year, even though patients with a device were at more than double the risk of a serious adverse event during followup compared with medically managed patients.
, http://www.100md.com
For patients in the device group, "the timing of adverse events was scattered throughout their course," Dr. Rose told Reuters Health. "Many had an adverse event who did better after their adverse event, particularly the early postoperative bleeding issues and neurological dysfunction. In past generations, virtually everyone on a device like this had a stroke. That was clearly not the case in this study, where only about 10% of the patients on a device did."
In the journal paper, the investigators express the hope that, in addition to improving care for patients with end-stage heart failure, such devices will become a viable therapy for patients with less severe heart-failure syndromes. "Even lesser degrees of heart failure are still mortal illnesses," Dr. Rose said. "The quality of life of those patients is still severely impaired."
, http://www.100md.com
He added that with the aid of devices such as HeartMate, patients could even expect to return to work. "The results in REMATCH in the 22 patients less than 60 years of age were absolutely stunning. The 74% one-year survival brings it up almost to the performance of transplantation," Dr. Rose pointed out.
Thoratec announced that it has submitted data from this trial to the US Food and Drug Administration, seeking a new indication for HeartMate. If approved, it would be the first ventricular assist device indicated for end-stage heart failure.
, 百拇医药
"Technology will ultimately solve many of the problems involved in applying mechanical cardiac support therapy to a wide spectrum of patients with heart failure," Dr. Mariell Jessup, of the Hospital of the University of Pennsylvania in Philadelphia, predicts in an editorial. She points out, however, that the cost per year of life gained may be too much for society to bear., http://www.100md.com