FDA Approves Chest-Implanted LVAD

The HeartWare Ventricular Assist System, a small left ventricular assist device that is implanted in the chest instead of the abdomen, has been approved by the Food and Drug Administration as a bridge to heart transplant for end-stage heart failure patients.

The HeartWare Ventricular Assist System, manufactured by HeartWare, includes an implantable pump with an external driver and power source. The device is another treatment option for advanced heart failure patients, especially those who are smaller in size or can’t have an abdominal implant.

The approval of the continuous-flow pump device comes less than 3 years after the agency approved Thoratec’s HeartMate II left ventricular assist device (LVAD) for destination therapy. That device quickly replaced the previous generation of pulsatile-flow devices.

This is the first time that the FDA has approved a ventricular assist device using comparator data from a registry as a control, according to the agency.

The approval was based on data from the ADVANCE trial, which compared the outcomes of 137 patients implanted with the HeartWare System and of patients registered by the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). The registry has been in place since 2005, collecting information on patients who received an approved mechanical circulatory support device implant.

A total of 140 patients received the investigational pump, and 499 patients received a commercially available pump implanted contemporaneously. At 180 days, 90.7% of the investigational pump patients and 90.1% of the controls had survived, establishing the noninferiority of the investigational pump (P less than .001; 15% noninferiority margin). Infection, right heart failure, device replacement, stroke, kidney dysfunction, hemolysis, and arrhythmia rates for the HVAD were similar to those reported previously for the HeartMate II, according to Dr. Keith D. Aaronson and his colleagues in the study (Circulation. 2012;125:3191-3200).

Results of the ADVANCE trial showed that at 6 months, median 6-minute walk distance improved by 128.5 m, and "functional capacity and quality of life improved markedly, and the adverse event profile was favorable," according to the authors.

In a news release, FDA officials noted that "although rates of most key adverse events were comparable, the risk of stroke associated with the HeartWare LVAD necessitates patients and clinicians to discuss all treatment options before deciding to use the device."

"Well-designed registries in targeted product areas can enhance the public health and provide a cost-effective approach to clinical research for industry innovators," Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in a statement. For HeartWare, registry data directly facilitated the development and availability of this new device. The registry is a joint effort involving the FDA; National Heart, Lung, and Blood Institute; Centers for Medicare and Medicaid Services (CMS); and clinicians, scientists, and industry.

The FDA approval of the bridge-to-transplant pump comes on the heels of a Medicare Advisory (MEDCAC) meeting, where heart societies and prominent heart failure experts discussed the state of VAD research. The panel stressed the importance of multidisciplinary heart teams, and said that there’s not enough data to show that the indications for VADs can be expanded to include lower-risk patients.

Medicare currently does not have an open National Coverage Determination (NCD) for VADs. Medicare currently reimburses VADs, under certain criteria, as a bridge-to-transplant and as destination therapy.

Dr. Sean Pinney, who spoke at the MEDCAC meeting on behalf of the Heart Failure Society of America, said that the society supported the NCD and did "not endorse any change in the current patient selection criteria which derive from prospective randomized trials." He added that there’s a need for more well-controlled clinical trials, including those that would examine "less sick" patients.

"We do not endorse expansion of destination therapy into this population in the absence of randomized clinical trials," said Dr. Pinney, associate professor of medicine at Mount Sinai Medical Center in New York.

The 140 U.S. centers that place LVADs are expected to implant nearly 3,000 devices this year. Nearly 4,600 patients have received an LVAD since 2010.

"This is a rapidly evolving field," said Dr. Mariell Jessup, president-elect of the American Heart Association and professor of medicine at the University of Pennsylvania Heart & Vascular Center in Philadelphia. "It’s only to be expected that CMS would open coverage determination. It’s a costly technology, and outcomes are a lot better than several years ago," she said.

Physicians quoted in this story reported no financial conflicts.

The HeartWare Ventricular Assist System, a small left ventricular assist device that is implanted in the chest instead of the abdomen, has been approved by the Food and Drug Administration as a bridge to heart transplant for end-stage heart failure patients.

The HeartWare Ventricular Assist System, manufactured by HeartWare, includes an implantable pump with an external driver and power source. The device is another treatment option for advanced heart failure patients, especially those who are smaller in size or can’t have an abdominal implant.

The approval of the continuous-flow pump device comes less than 3 years after the agency approved Thoratec’s HeartMate II left ventricular assist device (LVAD) for destination therapy. That device quickly replaced the previous generation of pulsatile-flow devices.

This is the first time that the FDA has approved a ventricular assist device using comparator data from a registry as a control, according to the agency.

The approval was based on data from the ADVANCE trial, which compared the outcomes of 137 patients implanted with the HeartWare System and of patients registered by the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). The registry has been in place since 2005, collecting information on patients who received an approved mechanical circulatory support device implant.

A total of 140 patients received the investigational pump, and 499 patients received a commercially available pump implanted contemporaneously. At 180 days, 90.7% of the investigational pump patients and 90.1% of the controls had survived, establishing the noninferiority of the investigational pump (P less than .001; 15% noninferiority margin). Infection, right heart failure, device replacement, stroke, kidney dysfunction, hemolysis, and arrhythmia rates for the HVAD were similar to those reported previously for the HeartMate II, according to Dr. Keith D. Aaronson and his colleagues in the study (Circulation. 2012;125:3191-3200).

Results of the ADVANCE trial showed that at 6 months, median 6-minute walk distance improved by 128.5 m, and "functional capacity and quality of life improved markedly, and the adverse event profile was favorable," according to the authors.

In a news release, FDA officials noted that "although rates of most key adverse events were comparable, the risk of stroke associated with the HeartWare LVAD necessitates patients and clinicians to discuss all treatment options before deciding to use the device."

"Well-designed registries in targeted product areas can enhance the public health and provide a cost-effective approach to clinical research for industry innovators," Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in a statement. For HeartWare, registry data directly facilitated the development and availability of this new device. The registry is a joint effort involving the FDA; National Heart, Lung, and Blood Institute; Centers for Medicare and Medicaid Services (CMS); and clinicians, scientists, and industry.

The FDA approval of the bridge-to-transplant pump comes on the heels of a Medicare Advisory (MEDCAC) meeting, where heart societies and prominent heart failure experts discussed the state of VAD research. The panel stressed the importance of multidisciplinary heart teams, and said that there’s not enough data to show that the indications for VADs can be expanded to include lower-risk patients.

Medicare currently does not have an open National Coverage Determination (NCD) for VADs. Medicare currently reimburses VADs, under certain criteria, as a bridge-to-transplant and as destination therapy.

Dr. Sean Pinney, who spoke at the MEDCAC meeting on behalf of the Heart Failure Society of America, said that the society supported the NCD and did "not endorse any change in the current patient selection criteria which derive from prospective randomized trials." He added that there’s a need for more well-controlled clinical trials, including those that would examine "less sick" patients.

"We do not endorse expansion of destination therapy into this population in the absence of randomized clinical trials," said Dr. Pinney, associate professor of medicine at Mount Sinai Medical Center in New York.

The 140 U.S. centers that place LVADs are expected to implant nearly 3,000 devices this year. Nearly 4,600 patients have received an LVAD since 2010.

"This is a rapidly evolving field," said Dr. Mariell Jessup, president-elect of the American Heart Association and professor of medicine at the University of Pennsylvania Heart & Vascular Center in Philadelphia. "It’s only to be expected that CMS would open coverage determination. It’s a costly technology, and outcomes are a lot better than several years ago," she said.

Physicians quoted in this story reported no financial conflicts.

The HeartWare Ventricular Assist System, a small left ventricular assist device that is implanted in the chest instead of the abdomen, has been approved by the Food and Drug Administration as a bridge to heart transplant for end-stage heart failure patients.

The HeartWare Ventricular Assist System, manufactured by HeartWare, includes an implantable pump with an external driver and power source. The device is another treatment option for advanced heart failure patients, especially those who are smaller in size or can’t have an abdominal implant.

The approval of the continuous-flow pump device comes less than 3 years after the agency approved Thoratec’s HeartMate II left ventricular assist device (LVAD) for destination therapy. That device quickly replaced the previous generation of pulsatile-flow devices.

This is the first time that the FDA has approved a ventricular assist device using comparator data from a registry as a control, according to the agency.

The approval was based on data from the ADVANCE trial, which compared the outcomes of 137 patients implanted with the HeartWare System and of patients registered by the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). The registry has been in place since 2005, collecting information on patients who received an approved mechanical circulatory support device implant.

A total of 140 patients received the investigational pump, and 499 patients received a commercially available pump implanted contemporaneously. At 180 days, 90.7% of the investigational pump patients and 90.1% of the controls had survived, establishing the noninferiority of the investigational pump (P less than .001; 15% noninferiority margin). Infection, right heart failure, device replacement, stroke, kidney dysfunction, hemolysis, and arrhythmia rates for the HVAD were similar to those reported previously for the HeartMate II, according to Dr. Keith D. Aaronson and his colleagues in the study (Circulation. 2012;125:3191-3200).

Results of the ADVANCE trial showed that at 6 months, median 6-minute walk distance improved by 128.5 m, and "functional capacity and quality of life improved markedly, and the adverse event profile was favorable," according to the authors.

In a news release, FDA officials noted that "although rates of most key adverse events were comparable, the risk of stroke associated with the HeartWare LVAD necessitates patients and clinicians to discuss all treatment options before deciding to use the device."

"Well-designed registries in targeted product areas can enhance the public health and provide a cost-effective approach to clinical research for industry innovators," Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in a statement. For HeartWare, registry data directly facilitated the development and availability of this new device. The registry is a joint effort involving the FDA; National Heart, Lung, and Blood Institute; Centers for Medicare and Medicaid Services (CMS); and clinicians, scientists, and industry.

The FDA approval of the bridge-to-transplant pump comes on the heels of a Medicare Advisory (MEDCAC) meeting, where heart societies and prominent heart failure experts discussed the state of VAD research. The panel stressed the importance of multidisciplinary heart teams, and said that there’s not enough data to show that the indications for VADs can be expanded to include lower-risk patients.

Medicare currently does not have an open National Coverage Determination (NCD) for VADs. Medicare currently reimburses VADs, under certain criteria, as a bridge-to-transplant and as destination therapy.

Dr. Sean Pinney, who spoke at the MEDCAC meeting on behalf of the Heart Failure Society of America, said that the society supported the NCD and did "not endorse any change in the current patient selection criteria which derive from prospective randomized trials." He added that there’s a need for more well-controlled clinical trials, including those that would examine "less sick" patients.

"We do not endorse expansion of destination therapy into this population in the absence of randomized clinical trials," said Dr. Pinney, associate professor of medicine at Mount Sinai Medical Center in New York.

The 140 U.S. centers that place LVADs are expected to implant nearly 3,000 devices this year. Nearly 4,600 patients have received an LVAD since 2010.

"This is a rapidly evolving field," said Dr. Mariell Jessup, president-elect of the American Heart Association and professor of medicine at the University of Pennsylvania Heart & Vascular Center in Philadelphia. "It’s only to be expected that CMS would open coverage determination. It’s a costly technology, and outcomes are a lot better than several years ago," she said.

Physicians quoted in this story reported no financial conflicts.